CN101810521B - Satiation devices and methods - Google Patents

Abstract

The invention relates to satiation devices and methods. A device for inducing weight loss in a patient includes a tubular prosthesis positionable at the gastro-esophageal junction region, preferably below the z-line. In a method for inducing weight loss, the prosthesis is placed such that an opening at its proximal end receives masticated food from the esophagus, and such that the masticated food passes through the pouch and into the stomach via an opening in its distal end.

Description

Satiation devices and method

The divisional application that the present invention is application number is 03812874.8, the applying date is the application for a patent for invention on February 13rd, 2003.

Invention field

The present invention's generality relates to the field making human body realize the apparatus and method lost weight, and in particular to human implantable gastric for controlling the application of the device of hunger sensation.

background of invention

Plurality of medical approach is used to obesity controlling.These approach comprise go on a diet, medicine and operation method.More successful surgical method is the gastroplexy of vertical zone circle or the near-end gastric pouch that adopts Roux-en-Y anastomosis to complete, so that shunts food makes it can not enter intestinal by the proximal end region of stomach, reduces food absorption thus to greatest extent in blood flow.But these methods known all there is complication separately and people need more successfully to select.

Additive method comprises implants abrasive net-balloon for stomach (gastric balloon), and the volume thus by occupying gastric prevents hyperalimentation.Unfortunately, abrasive net-balloon for stomach can transfer to downwards GI road, causes and blocks and have to be removed.

Therefore existing method is replaced to reach obesity controlling desirable to provide the method that successful Interventional is minimum.

Summary of the invention

summary of the invention

A kind of utilize the Satiation devices of the principle of the invention to comprise tubular pouch that one can be positioned on stomach esophagus junction.This capsule has a proximal openings received from the dietary intake of esophagus, and food in this capsule is sent to the distal openings of gastric by one.This capsule is proportional, carries out comparatively slow, cause food to be accumulated in this capsule with the transmission activity making food enter gastric from this capsule, patient is had swell sense.

accompanying drawing is sketched

Fig. 1 is the schematic diagram of a human stomach and part small intestinal.

Fig. 2 is the schematic diagram similar with Fig. 1, position in the body of expression gastric pouch.

Fig. 3 is the side cross-sectional view of a transmission system, and it may be used for the capsule of transmission Satiation devices such as Fig. 2.

Fig. 4 A is the cross-sectional end view of the propulsion tube of the transmission system of Fig. 3.

Fig. 4 B is another cross-sectional end view of the propulsion tube of the transmission system that may be used for Fig. 3.

Fig. 5 is that the transfer body of Fig. 3 ties up to and transmits capsule and enter side cross-sectional view in stomach esophagus junction process.

Fig. 6 further illustrates and is sent in stomach esophagus junction by capsule.Do not show this transmission system, thus capsule and suture are more easily seen clearly.

Fig. 7 illustrates the rearmost position of the capsule of Fig. 6.

Fig. 8 is the another kind of perspective view using the capsule of seaming loop.

Fig. 9 A and 9B is that another uses perspective view and the top plan view of the capsule of seaming loop respectively.

Figure 10 is another embodiment of the capsule using seaming loop, and illustrates the shape of another capsule.

Figure 11 is one and represents the schematic diagram using the capsule of seaming loop to be positioned at stomach esophagus junction.

Figure 12 is the schematic diagram being similar to Figure 11, represents another capsule comprising independent implantable seaming loop.

Figure 13 A and 13B is schematic diagram, represents coaxial folding (plication) device used, and wherein Figure 13 A represents the position of this conduit after circle is located and Figure 13 B represents folding formation and the placement of retainer.

Figure 14 A is the schematic diagram of another folding device of expression.

Figure 14 B is a folding perspective view utilizing the tissue of the device of Figure 14 A.

Figure 15 is the perspective view of an expandable bladder.

Figure 16 represents that the use transporter of Figure 15 transmits the schematic diagram of capsule.

Position in the body that Figure 17 illustrates another gastric pouch.

Figure 18 A be the gastric pouch of Figure 17 at one for the perspective view in the positioning pipe sleeve that transmits.

The perspective view of gastric pouch in expansion process of Figure 18 B Figure 17.Capsule demonstrates by from positioning pipe sleeve transmission but still be connected with footstalk.

Figure 19 is the perspective view of another gastric pouch embodiment.

Figure 20 A is the perspective view of another gastric pouch, and it adopts coil configuration.

Figure 20 B is the side cross-sectional view of the gastric pouch of Figure 20 A.

Figure 21 A is a schematic diagram, represents the substrate frame combined with gastric pouch.

Figure 21 B is the schematic diagram being similar to Fig. 2 A, but further illustrates (alignment) extending part that aligns with gastric pouch and holder combination.

Figure 22 A represents another gastric pouch embodiment.

Figure 22 B is the sectional view of the gastric pouch sidewall of Figure 22 A.

Figure 22 C is the perspective view in the far-end skewed slot district of the gastric pouch of Figure 22 A.

Figure 22 D is the perspective view in a kind of far-end skewed slot district in the far-end skewed slot district replacing Figure 22 C.

Figure 23 is another transporter, may be used for together transmitting gastric pouch.

Figure 24 A and 24B is the end-view of the transporter of Figure 23, is illustrated respectively in the pawl of aperture position and make position.

Figure 25 A and 25B is a series of side view, and it represents the linking that Satiation devices was undertaken by transporter before implanting with transporter.

Figure 26 represents the perspective view of another gastric pouch.

Figure 27 A and 27B is top plan view, represents the circle type used in the embodiment of Figure 26.Show this circle in Figure 27 A be in compressive state and in Figure 27 B, be in natural, deployed condition.

Figure 28 A is the perspective view of another embodiment of full capsule.

Figure 28 B is the schematic diagram of the body inner position of the capsule of Figure 28 A.

Figure 29 diagram is through the body inner position of the capsule of esophagus.

Figure 30 illustrates the body inner position that another wears the capsule of esophagus.

Figure 31 is the front view of the full capsule with scalable distal openings.

Figure 32 A is the front view of the full capsule with another scalable distal openings form.

Figure 32 B is the top plan view of the scalable delimiter circle of the capsule of Figure 32 A.

Figure 33 is the full capsule with another adjustable distal openings form, and the side view that can be used for the instrument adjusting this distal openings.

Figure 34 A and 34B represents that the distal portion other places of the instrument shown in Figure 33 are in regaining and the side view of extended configuration.

Figure 35 A and 35B is the top plan view of the adjustable limiter circle of the capsule of Figure 33, represents that this ring is in stretching, extension and contraction state.

Figure 36 A-36D is one group and schematically illustrates the figure taking out full capsule from patient.

Figure 37 is the side cross-sectional view of capsule disassembling tool, and it can use with the tool combinations shown in Figure 36 A-36D.

Figure 38 A and 38B is the schematic diagram of harmonization of the stomach esophagus, represents the full capsule with safety leash.

Detailed description of the invention

detailed Description Of The Invention

The anatomical view of human stomach S and features relevant is illustrated in Fig. 1.Esophagus E by the food delivery in oral cavity to stomach S.Z-line or stomach esophagus junction Z are the erose borders between the thin tissue and the thicker tissue of coat of the stomach of esophagus.Stomach esophageal junction region G is the region comprising the distal portions of esophagus E, the proximal part of z-line stomach function regulating S.

The numerous embodiments of Satiation devices is described herein.These devices many comprise a capsule being positioned at stomach esophageal junction region or funnel with formed one collect from the food chewed of esophagus little bank-erstricted diet can for the amount of the food consumed simultaneously thus.Along with the time, the food in this bank drops to gastric through the distal openings of this capsule.This capsule optionally can comprise and can be positioned in esophagus to promote that food to be flowed into the tubulose extension in capsule by esophagus.

The material that can be used for this capsule comprises the flexible material preventing food from passing capsule avris.The example of this type of material includes, but are not limited to polyester (such as Dacron polyester), ePTFE fabric (such as GoreTex fabric or other), polyurethane is ChronoFlex such as polyurethane, nylon fabrics, siloxanes, other polymeric materials, and bioabsorbable material (such as PLLA, PGA, PCL, poly-amhydride etc.).Capsule 12 can be made up of flexible, half composite that is flexible and/or non-compliant materials, and they make the capsule of zones of different have flexibility in various degree, allow/limit capsule in the stretching of different loci thus.For example, wish the capsule obtaining there is suitable elastic exit port, thus prevent from, in the activity of picked-up bulk food, obturation occurs, and the near-end of capsule can be harder to prevent bulging.Capsule can also be made to have flexibility in various degree by changing capsule zones of different capsula interna section thickness.Capsule material can cover, thus reduce suprabasil friction with level and smooth, biocompatible, chemical inert material such as paraleyne.

Flexible pouch material can be delivered by supporting structure, such as soft net, coil, supporting structure, floor, circle etc.Supporting structure can by rustless steel, polymer, shape-memory material (such as nitinol (nitinol), marmem, or shape-memory polymer), bioabsorbable material form, or, when siloxanes capsule, be made up of the siloxanes of thickened areas.Supporting structure can be positioned at inside or the outside of flexible pouch material.Can be molded into or be sewn onto in capsule material, or can be adhered to suitable binding agent.If when using the coil of the net of close weave or closely distortion, can flexible pouch material be removed.In addition, net can be embedded in polymeric material in net space, can remove separate internal or the outer cover of capsule material in this case.

Preferably described capsule is configured to and can expands voluntarily, and this capsule radial direction when being sprayed by the expanding unit hereafter described in detail or conduit is flicked becomes deployed condition.

In many embodiments, this scrotiform funneling shape.But other shapes many also can be used for described capsule.For example, this capsule can have shorter near-end to distal dimension and thus in saucer shape and in its lower surface, there is an aperture.Other embodiments include, but not limited to avette, the shape of other tapers such as " gyro ", cylindrical shape, and other symmetrical or asymmetric shapes.

Described device can modularity, wherein implants multiple assembly.Many assemblies can be provided separately from each other.In such module system, the assembly separately implanted can be connected to each other and be positioned at housing in implantation process, even if or some assembly wherein be also be not connected each other after the implantation.In addition, assembly can assemble by doctor each other immediately before implantation.Modular assembly is desirable, and wherein they allow doctor to select the various assemblies of suitable size for patient.

An embodiment of Satiation devices as shown in Figure 2 and comprise the capsule 12 being positioned at stomach proximal end region.Capsule 12 comprises the shown proximal openings 14 (and preferably lower than z-line) that can be positioned on stomach esophageal junction region, and to the distal openings 16 that stomach S inside is opened.In this embodiment, capsule 12 by proximal openings outwards gradually taper attenuate and form apron 18, and subsequently to interior gradually conically distally opening 16 attenuate, make the distal portions of capsule 12 be funnel shaped.But other shapes many are also applicable to described capsule.For example, capsule can have very short near-end also becomes saucer thus shape to distal dimension, has an aperture at its basal surface simultaneously.

Due to its volume little (its volume can in the grade of about 2cc-300cc, but preferably in the scope of 10-30cc), the effect of capsule is to limit can by the amount of food consumed simultaneously.Capsule 12 can be made up of the flexible material preventing food from passing capsule side, such as Dacron polyester, siloxanes, or other polymeric materials.Capsule 12 can be made up of flexible, half composite that is flexible and/or non-compliant materials, and it makes the zones of different of capsule have flexibility in various degree.This type of composite allows/limits capsule to extend to diverse location, contribute to thus controlling foodstuff through this capsule through speed and/or the food discharge pressure from this capsule.If use siloxanes, can be this capsule structure flexibility in various degree by the capsule section thickness changed in the zones of different of capsule.Capsule material can cover with level and smooth, biocompatible, chemical inert material such as paraleyne, thus reduces the friction on the surface of base material, and this contributes to preventing adhesion and food build-up on the apparatus.

In implantation process, capsule 12 stitching, clip, binding agent or other appropriate ways are fixed on stomach esophageal junction region G.Although this capsule can be fixed on esophageal tissue, more preferably use under Z-line sew up/clamping thus be attached to the thicker tissue of coat of the stomach.Suture attachment points, can take the form 20 of hole, eyelet or buttonhole in this capsule, it may be used for stomach anchor suture provides stabilization zone.Although this type of the amount doesn't matter stitching/clip attachment points can be used as required, need the point that at least four are such, such as in this capsule surrounding with the interval of 90 °, guarantee that this capsule is fixed on the whole periphery of tissue thus.Suture attachment points can be made up of the radiopacity material of suitable density, such as titanium or gold, thus makes this device visible in operation or afterwards.Each suture attachment points also can with different colours labelling to be convenient to identification and the orientation of stitching.If this capsule is made up of siloxanes, the proximal part (its perforations 20 is located) of this capsule can be made up of more durable material, such as textile material, Dacron in siloxanes polyester or ePTFE fabric, thus obtain more durable suture zone.Although buttonhole, eyelet or stabilization zone can be favourable, also can provide the capsule of the suture attachment points be not made up of special material (have or without recognition marks)-sew up in this case directly through capsule material.

Flexible pouch material can be carried by support, such as soft net, supporting structure, floor, circle etc.Support can by rustless steel, polymer, shape-memory material such as nitinol, marmem, or shape-memory polymer is formed, or the buildup area of capsule material is formed.Preferably make this capsule be configured to can expand voluntarily, this capsule radial direction when being sprayed by the expanding unit hereafter described in detail or conduit is flicked becomes deployed condition.

Fig. 3 represents a kind of transmission system 22, and it can be used for implanting capsule 12 and any other Satiation devices as herein described.Transmission system 22 comprises extends pipe box 24 and the propulsion tube 26 accepted that can slide in this cover.Pipe box 24 comprises a far-end 28, and it is slightly tapered and be made up of flexible material such as soft polyethylene, thus reduce to greatest extent due to end 28 to move in esophagus stomach function regulating and motion wherein time contact the wound caused with body tissue.

Propulsion tube 26 be along pipe box 24 extend extension tubing and slightly from the proximal extension of pipe box 24.Handle 30 can be formed so that promote that this propulsion tube moves relative to pipe box 24 at the near-end of this propulsion tube 26.Propulsion tube 26 comprises cavity 32, for holding the device needed for implantation position.Such device can comprise, and such as, implant can be made to operate visible endoscope 34, or other guarantees that implant suitably places the device that may need.Many cast chambeies 36 (Fig. 4 A) and/or groove 38 (Fig. 4 B) are positioned at the periphery of propulsion tube 26.In use, stitching thread can be positioned in these chamber/grooves and make stitching thread be separated from each other thus.

See Fig. 5, in the implantation of capsule 12 prepares, stitching thread 40 is fixed on eyelet 20 place of capsule, and this capsule folds or rolls and is placed in the far-end of pipe box 24.The near-end of each sutural near-end place of drawing pipe box 24 also passes through the chamber 36 (Fig. 4 A) of propulsion tube 26 or slit 36 (Fig. 4 B).The far-end of each sutural far-end pull-out pipe box 24.This stitching thread can color different or have that different coloured patterns-it can correspond to the color of stitch points on capsule, thus can identify easily and distinguish each stitching thread.Secondly, propulsion tube 26 enters in pipe box 24 and makes its distal face to folding capsule 12.

The far-end of pipe box 24 through esophagus across and into stomach.The free distal end of stitching thread 40 is stitched through the tissue of esophagus opening surrounding, suitable just below Z line.This stitching can connect as required under endoscope direction, uses conventional stitching techniques.See Fig. 5 and 6.Pipe box 24 does not represent in figure 6, makes funnel and sew up to see more clearly.

Be fixed to once stitching thread and organized, propulsion tube 26 handle 30 distal direction advances.Propulsion tube 26 makes capsule 12 leave the distal openings of pipe box 24.Pipe box 24 eyelet 20 is positioned at suture location, as shown in Figure 7.Knot 42 pricks bundle, and each is sewed up and along the running lengthwise sewed up to tissue, thus capsule is fixed on certain position.

Once implant, capsule limits the passage that the intraesophageal food of patient enters into stomach.Can believe that the pressure receptor in stomach substrate stomach function regulating esophageal junction region will bring out satiety owing to collecting food and remaining in the bank of this capsule.Gravity and column power enter ordering about food by the restricted entry of bank the gastric carrying out normal stool.

Fig. 8 represents the second embodiment of capsule 44.Capsule 44 comprises elasticity or half flexible material (such as, durable polyurethane elastomer such as ChronoFlex polyurethane, siloxanes, ePTFE net or fabric, Dacron net or fabric).Described capsule can also form by the composite of flexible (or half is flexible) and non-compliant materials the region making this capsule have different flexibility thus.Capsule 44 can comprise ruggedized construction such as spiral floor or circle 46-, and it can be made up of nitinol, rustless steel, plastics etc.Ruggedized construction can be molded or be sewn in capsule material, maybe can bond with suitable binding agent.Can contain or not form circle containing perforated seam circle 48 in proximal openings 50 surrounding.For all illustrated embodiments, described capsule can inwardly distally opening 52 be conically tapered to form funnel shaped-or described capsule can have a kind of different other shapes above-mentioned.

The third capsule 54 as illustrated in figures 9a and 9b.Capsule 54 is similar to the capsule of Fig. 8 but comprises eyelet 56 further at seam circle 62, and slightly cylindrical chute 58 is adjacent with distal openings 60.4th seed capsules 63, as shown in Figure 10, also comprise seam circle 62a, but difference are that its global shape is more shallow and little infundibulate.

As shown in figure 11, use the capsule (capsule 54 of capsule 44, Fig. 9 A of such as Fig. 8, or the capsule 62 of Figure 10) of seam circle 65 preferably to sew up or fold location or be attached to the tissue on stomach S top.Wish that this location is in order to avoid being sewn to thinner esophageal tissue.Because the tissue of coat of the stomach is thicker than esophageal tissue, so preferable stitching surface can be obtained: or, as shown in figure 12, can be that the seam circle 64 of nitinol or polymer can separate with relevant capsule 66 and implants, and sew up before introducing capsule 66 and enter or fold in gastric tissue.After this, introduce capsule 66 and be connected with circle 64 with suture, clip or other attachment mechanisms.

For the ease of the stitching of capsule, such as those capsules as herein described, may wish to form pleat-to be similar to pleating or " frenulum " mode of operation of carrying out in treatment gastro-intestinal reflux disease at in-house stomach esophageal junction region suture.This histioid pleat is suitable for being formed under z-line in gastric tissue, and is radially inwardly stretched on a small quantity by coat of the stomach.These are folded in attachment capsule process is more convenient for receiving sewing needle or clip to be also easy to the implantation of capsule thus.

Two kinds of mechanisms forming inverted pleat in gastric tissue are as shown in Figure 13 A, 13B and 14A, 14B.See Figure 13 A, the first folding device comprises the circle 68 with central opening 67 and multiple spaced apart circumferential opening 69.Circle 68 can be positioned on shown nearside stomach (if needing to use pipe box so that insert and place), makes circumferential openings 69 contact with the gastric tissue of distal esophagus opening surrounding thus.Conduit 72 can extend through central opening 67.See Figure 13 B, Tissue puller 70 can vertically move through conduit.Tissue puller 70 can be taked the form-of the extension line with spiral top but other also can be taked can to connect and draw the form of dragging tissue.

The flexible retainer 71 with central opening is configured as to engage and draws through it tissue (such as star-shaped openings) dragged, and this retainer can move through conduit 72 and puller 70.

In order to the device of Figure 13 A, 13B by pleating for organizing of stomach esophageal junction region, circle 68 can position relative to the gastric tissue shown in Figure 13 A.Conduit 72 is through central opening 67, and the position below its far-end is directed in circle 68 a opening 69.See Figure 13 B, this puller 70 in advance through opening 69 until gastric tissue above its contact ring 68, and by regaining puller 70 from opening 69, the gastric tissue of connection to be pulled out through opening 69 subsequently.Vacuum can be applied by conduit 72, pull out through opening 69 with facilitate tissue.Keep the withdrawal of puller, retainer 71 is advanced in conduit 72 and puller 70, and advance through opening 69-downwards along the cone C of tissue further and cause organizing cone to be extended in retainer by star-shaped openings also forming inverted pleat thus.The point that this retainer utilizes star-shaped openings to be formed pins tissue to keep inverted pleat.Other barbs or hook can be used so that locking.This method can adopt in some or all residue openings 69 and form inverted pleat with the gastric tissue multiple retainer 71 being connected to esophagus periphery-thus in esophagus surrounding in circle 68.After this capsule such as herein described those are stitched into inverted pleat, or are connected with circle 68 by suture, clip, binding agent or other appropriate device.

Another kind of folding device as shown in figs. 14 a-b and comprise the annular ring 73 with multiple circumferential openings 74.Circle 73 can be made up of airframe material.Multiple folded clip 75 comprises jaw element, and it extends through the adjacent apertures 74 in the circle 73 shown in Figure 14 B.Separable driver 77 can open and close the jaw element of folded clip 75.In order to folded tissue, circle 73 is positioned at stomach-esophageal junction region, and its upper surface contacts with the tissue of nearside stomach simultaneously, is centered around the opening part to esophagus.The jaw element of folded clip passes opening 74 and organizes for firmly grasping, as shown in Figure 14B-and in tissue, form inverted pleat thus and this circle is remained on certain position.Close jaw element, and utilize the tissue grasped to be locked in make position therebetween.Driver 77 is separated with clip, makes circle and clip stay appropriate location thus maintains in-house inverted pleat.Full capsule can be sewn to the in-house inverted pleat herein described in numerous embodiments subsequently, or be connected with circle 73 by suture, clip, binding agent or other suitable adhering mode.

Figure 15 and 16 represents the embodiment of capsule 78, and it is different from preceding embodiment, and wherein it is formed as having air chamber 79, close to the expansion valve 82 of proximal openings 80 and the inflatable cup of separable expansion tube 84.Sew up eyelet 86 and be centered around proximal openings.When capsule 78 self-deploy sleeve pipe 88 be deployed into gastric after (see Figure 16), by syringe by making it expand in injection inflation medium (such as air or saline) to expansion tube 84, and capsule is separated with pipe 84 with valve 82.When hope removing capsule, sting capsule 78 and exit, pulling out through esophagus with endoscope's claw hook or similar means subsequently.

See Figure 17,18A and 18B, capsule 90 is made up of circle 92, and circle 92 is made up of self-expanding material, and such as rustless steel, nitinol or shape-memory polymer, with material such as Dacron polyester, ePTFE fabric or other polymer durable when being sewn onto adjacent body tissue cover.Circle 92 optionally links together with floor 94, and it also can be made up of shape-memory material.

Be tapered to the distal end taper of capsule 90 and enter chute 96.Chute 96 can be made up of the material being similar to capsule, or can be made up of elastomeric polymer, such as soft polyethylene, siloxanes, elastomer polyurethane material etc.Allow chute radial expansion thus.Entrained by this response chute, the expansion of the accumulation of food material may be needs, thus prevents chute from blocking.Chute 96 is collapsible and play the effect of test valve-prevent raw material to be back in capsule by stomach thus.

Cycling suturing district 98 is positioned at the near-end of capsule.In implantation process, sew up and to be connected with suture zone and to be fixed on adjacent tissue.For the ease of capsule stitching in position, wish with suture in stomach esophageal junction region formative tissue inverted pleat-to be similar to pleating or " frenulum " mode of operation of carrying out in treatment gastro-intestinal reflux disease.This class loading pleat is radially inwardly stretched on a small quantity by coat of the stomach.These are folded in connect in capsule process and are more convenient for receiving sewing needle or clip.

Capsule 90 can provide by transmission system, and this transmission system comprises the elongation footstalk 100 extended through capsule 90.Nose-cone 102 is connected with the far-end of this footstalk, and comprises wire 104.Nose-cone 102 is preferably pliability and sharp-pointed or root face freely, thus prevents tissue injury in implantation process.

As shown in Figure 18 A, capsule 90 folds and is packaged in positioning pipe sleeve 106, and pebax, FEP, ePTFE that this pipe box is reinforced by polymer such as line or other suitable materials form.This capsule folds around this footstalk, and after this folding capsule and footstalk are positioned in pipe box.Multiple folding can be adopted to reach this object.Folding capsule can comprise two-way inverted pleat, or overlapping folds.The example of this type of inverted pleat comprises propeller folds, rabbit ear folds, saddle folds or cloverleaf folds.

When capsule described in implanting, this pipe box 106 (being positioned at capsule) is incorporated into esophagus, and simultaneously first wire 104 passes esophagus and enters stomach.Once suture zone 98 arrives stomach-esophageal junction region, extract pipe box 106 out, bullet is deployed condition as shown in figure 18b because enclosing the extensibility voluntarily of 92 to make this capsule.Apply slight tension force to central footstalk according in Figure 18 B shown in arrow, thus make suture zone 98 by the tissue scaffold-around distal esophagus opening or supported by above-mentioned in-house inverted pleat.When suture zone 98 is supported by tissue by this way, this capsule, through suture zone and surrounding tissue, is fixed to the position shown in Figure 17 by suture thus.Once this capsule is sewn onto appropriate location, from patient, extract footstalk out, only this capsule is stayed appropriate location.After stitching, shift footstalk onto gastric, wherein extensible nose-cone tends to the distal openings that diameter is less than funnel, and removes through funnel and esophagus.

See Figure 19, the net that another seed capsules 108 can be made up of pillar 110 or (the comprising shape-memory polymer) that be made up of nitinol, rustless steel, polymer is formed.Circle 112 is connected to the pillar/net of this device proximal end, and also can be made up of nitinol, rustless steel, polymer (comprising shape-memory polymer).The outside or inside of this capsule is covered by the material 114 that can prevent food from passing capsule side.An example of this type of material is polyester material, the such as Dacron of DuPont sold polyester.

Figure 20 A and 20B represents another example of capsule 120.Capsule 120 is made up of shape memory coil, and this coil is heated as funnel shaped.Dacron polyester or other materials 122 (Figure 20 B) optionally can cover inwall or the outer wall of this coil, although this coil self may be small enough to the sidewall preventing food from migrating across this coil.Material 122 can be squeezed between nearest coil 124 and adjacent windings thereof, as shown in fig. 20b, makes it be fixed on appropriate location thus.

For other capsules as herein described, the capsule 108,120 that Figure 19-20B provides can have quite long near-end to distal dimension (such as the grade of about 1.5-5.0cm) makes this capsule become funnel shaped as shown in Figure 19 and 20A thus.But other shapes many may be used for this capsule.For example, this capsule can have very short near-end to distal dimension and take thus saucer shape and at its basal surface with aperture.

Gastric pouch also can be a part for larger Satiation devices.For example, see Figure 21 A, the proximal part of capsule 125 can connect the near-end of larger supporting structure 126.Support 126 expands to the proximal part of gastric antrum A from esophagus.It can be that shape structure is stretched in large exhibition, is preferably made up of self-expanding material, such as rustless steel or shape-memory material such as nitinol or polymer.Support 126 mainly plays a part to make flatulence cause satiety.According to shown, capsule 125 is suspended in the inside of support 126.

In addition, capsule 125 (use or do not use support 126) also can make its near-end be connected with the extending part 128 that aligns.See Figure 21 B, alignment extension 128 one extends to Endo-esophageal tubular stent portion.In one embodiment, the length of extension 128 can be about 5cm.It mainly plays makes the food of the proximal openings of capsule and the straight effect of esophagus-thus through esophagus, be easy to enter in this capsule.

Another embodiment of this bag apparatus as shown in fig. 22.Capsule 130 is preferably made up of silicone compositions.In the zones of different of this capsule, the section thickness of cyst wall can be different, allow/limit the expansion of the capsule of diverse location thus.Siloxanes or other materials can be covered by smooth, material that is biocompatible, chemically inertia, and such as paraleyne, so that the friction reducing to substrate material surface, contributes to preventing adhesion and food build-up on the apparatus thus.

Can be provided support element such as annular ring 132 and/or radial rib plate 134 (Figure 22 C).If used, this type of supporting element can be made up of the buildup area of siloxanes, or they can be separated by plastics or nitinol component.In a kind of example, as shown in fig. 22, the nitinol circle with waveform can give capsule 130 with structure.

Cervical region 136 is positioned at the near-end of capsule 130 and can be positioned on stomach esophageal junction region.In implantation process, with suture and clip, cervical region 136 is fixed on the surrounding of esophageal tissue and/or gastric tissue.Sewing hole in cervical region 136, eyelet or buttonhole 138 can provide stabilization zone for anchor suture.In addition, this reinforcing position and material can be made up of the radiopacity material of suitable density, such as titanium or gold, thus make this device visible in operation and afterwards.Reinforcing position and material can have different colors, thus also make suture identifiable design and differentiation.If needed, all or part of cervical region 340 can be made up of textile material at siloxanes place, obtains more durable suture zone thus.

Chute 140 is formed at the far-end of capsule 130.Chute 140 can comprise supporting element such as floor 134 (or circle such as encloses 132) for chute provides rigidity.In addition, collapsible chute such as chute 140a can be used, as shown in figure 22d.Chute 140a do not have floor support that this is collapsible be enough pliable and tough to shrink thus, so as response foodstuff by stomach reflux movement in chute 140a.

Funnel device also can reach by using bio-compatible shape binding agent, heat fusion or rf active fixation at the fixing of stomach esophageal junction region.

Capsule 130 and each seed capsules as herein described, can be sent to stomach esophageal junction region by transmission system, such as relevant with Fig. 3-5 a kind of system, or the transmission system using other kinds.Other transporters 142 as shown in figure 23.Device 142 comprises multiple grasping pawl 144 from extending sleeve pipe 146 extension.Pawl 144 comprises handle 148, and it can move along distal direction and make pawl 144 distally advance and make this pawl expand into the open mode shown in Figure 24 A simultaneously.Handle 148 motion proximally makes pawl 144 regain the closed condition become described in Figure 24 B, and this pawl is moved to the inside of sleeve pipe 146 simultaneously.

In use procedure, transporter 142 makes the near-end of this capsule or capsule (the such as capsule 130) edge join of far-end or end.When pawl 144 is closed, the end of their folding capsules, makes it engage and this capsule is pulled to (or optionally drawing in) sleeve pipe 146.If this pawl is used for engaging the far-end of capsule, as shown in fig. 25 a, this capsule preferably overturns in advance from inside to outside, and folds subsequently and get back to outside pawl 144, as shown in Figure 25 B, thus covers this pawl.The pawl 144 that tunica 130 covers passes esophagus and enters gastric to place this capsule, preferably carries out under endoscope direction.Be in stomach once capsule, this pawl 144 is opened and is discharged this capsule.Capsule is positioned at stomach esophageal junction region and is also tied a knot so that this capsule is fixed on appropriate location by the eyelet sewn through neighboring tissue of suture through this capsule.

Gastric pouch can also be used as the unique apparatus of Sutureless, and can remain on appropriate location under the radial expansion force effect of the pillar of this capsule structure, net or coils forming part on the contrary.An example of such capsule 150 as shown in figure 26.Capsule 150 comprises by flexible polymeric, nylon or Dacron the cervical region 152 of polyester composition.Multiple circle 154 is arranged in this cervical region.See Figure 27 A and 27B, each circle 154 comprises discontinuities 156, and its allows circle radial compression to appropriate state, as shown in fig. 27 a-while the discontinuities end that formed slightly overlap each other.Release causes its bullet to be ring-type to the compression of this circle, as shown in figure 27b.

Funnel part 158 is positioned at the far-end of this capsule.As described in the embodiment, when implanting capsule, cervical region 152 is arranged in stomach esophageal junction region (routine as directed distal esophagus) and funnel part 158 extends to gastric.

Before implantation, capsule 150 preferably wraps in pipe box (do not have diagram) and whole rings is compressive state, as shown in fig. 27 a.Once cervical region is placed in after in esophagus, extracts pipe box out, make circle 154 bullet be deployed condition, as shown in figure 27b.The circle launched is carried at sidewall or the stomach esophageal junction region of esophagus, keeps cervical region 154 and sidewall contact.Secondly the outside of cervical region 154 can optionally with hook 160, and the radial expansion of this circle makes hook be connected with the sidewall of surrounding thus.

Figure 28 A represents another seed capsules 162, and it comprises the cervical region 164 as suture zone.In implantation process, cervical region 164 to be retained in stomach-esophageal junction region and the remote extension of capsule 162 in stomach.Figure 28 B represents, this cervical region can be fixed on esophageal tissue's (although believing that tissue Z-line below may make more preferably attachment point according to discussing above).This cervical region and adjacent esophageal tissue bond to keep this capsule in position by preferred use biological adhesive.If use suture, be arranged in this cervical region expand voluntarily circle 166 can play effect-its surrounding of seaming loop can anchor suture.The chute 167 of far-end can comprise a spoonful shape valve, and its effect is the test valve as controlling gastroesophageal reflux.

Wear-two kinds of embodiments of esophageal satiation devices as shown in figures 29 and 30.See Figure 29, the elongated flexible device that capsule 168 is made up of variable-flexibility material, described material such as ePTFE, Dacron polyester or polyurethane such as ChronoFlex polyurethane.Capsule 168 comprises and can be positioned in esophagus and have the proximal part 170 of proximal openings 171.This capsule comprises elongation interlude further, and extend to gastric and comprise distal openings 172 far-end cone.The flexible nature of this capsule allows esophageal sphincter to bring into normal play function.

The proximal part 170 (it is arranged on the proximal location for esophageal sphincter) of this capsule can comprise the cylindrical stent structure expanded voluntarily, it is made up of shape-memory material such as nitinol, shape-memory polymer or marmem and to the radial pressure of sidewall generation around, makes thus himself to remain on Endo-esophageal appropriate location.This stretched out structure comprises barb to guarantee that capsule 168 cannot move away this position at its outer surface.In addition, proximal part 172 can be connected with around sidewall with suture or barb on the contrary.According to this scheme, this capsule can comprise stretched out structure or not this structure.

The embodiment of Figure 30 is slightly different from the embodiment of Figure 29, and difference is that wherein it comprises an optional tie-wrap restrictor 174, and its regulates food from this capsule, move to the speed of gastric.Band can carry out the flow velocity regulating to select this patient applicable in implantation process.In addition, the optional flapper valve 176 that can be positioned near esophageal sphincter contributes to preventing gastroesophageal reflux.The spoon shape valve 178 of distal openings 172 also can be used for stoping gastroesophageal reflux.

Full capsule can assemble, and the size of this capsule distal openings can be increased or reduce.Ensure that doctor implants this device and makes this distal openings be applicable to the size of patient thus.In some cases, doctor is also allowed to adjust distal openings after implantation.For example, if patient does not lose weight with goal pace, doctor can reduce the food of the size of distal openings-thus and be emptied to gastric from this capsule more lentamente.If if necessary lose weight too fast, doctor can also increase the size of this distal openings.

See Figure 31, longitudinal cut 180 can be formed, to increase the effective dimensions of distal openings at the far-end of this capsule.These otch use endoscopic scissors to cut after this capsule of implantation, or can cut before implantation.This device can bore a hole before cutting or groove with accelerate cutting.

See Figure 32 A and 32B, capsule 182 also can in outside this distal openings of surrounding-vicinity of this capsule with circle band 184.The expansion radial force stretch under application (such as graspings jaw is positioned in funnel and be separated jaw subsequently) that circle 184 can produce in this circle internal diameter, or apply compression stress to the outside of this circle and carry out compressing (be such as arranged between jaw by circle and also close it gently subsequently).This stretching, extension/compression is carried out after before implantation or can implanting this capsule.

Figure 33 represents the third embodiment of the capsule 186 with adjustable distal openings.Figure 33 embodiment is similar to Figure 32 A embodiment, and wherein it depends on the extend/retract of circle band.Circle band 188 is positioned in the capsule of adjacent distal end opening part.A pair relative slit 190 is positioned at the inner surface of circle 188.Endoscope's controllable adjustment instrument 192 comprises the extensible pin 194 of the distal tip being positioned at the axis of elongation 196 for a pair.The extension being positioned at the driver 198a in the proximal end of adjustment means 192, b control pin is between restriction state (Figure 34 A) and extended configuration (Figure 34 B).In order to adjust the diameter of capsule 186, this instrument is inserted through capsule and pin 194 is in restriction state.Pin 194 deeply to enclose in 188 along slit 190 and stretches with driver 198a subsequently.After they stretch, pin 194 slides in slit 190.After this, user along its longitudinal axis clockwise or this instrument 192 of counter rotation.The shape of instrument is launched or shrinks this circle, and this depends on the direction of rotation.After the size of circle adjusts, regain pin 194 with driver 198b, and take out instrument 192 from capsule 186 subsequently.

The full capsule in multiple technologies removing stomach can be utilized.A kind of example is as shown in Figure 36 A-36D.First, if adopt suture or clip, endoscopic scissors 202 direct oral cavity and esophagus pass and are used for cutting off suture (Figure 36 A) or removing clip.May wish to engage capsule 200, such as use is sewed through this capsule and is stretched out the band in oral cavity, or endoscope's claw hook etc., after being separated with stomach esophageal junction region, fall into gastric to prevent capsule further.

Secondly, pipe box 204 arrives stomach esophageal junction region through esophagus.Retrieval device 206 (can be similar to the device of Figure 23 those) with retractable pawl 208 makes its pawl 208 be in closed condition, and through pipe box.Open pawl 208, be positioned at the surrounding (Figure 36 B) of the proximal part of capsule 200, and close subsequently, this capsule is grabbed between pawl (Figure 36 C).With after extract pawl 208 take out this capsule (Figure 36 D) from body out through sleeve pipe.For the ease of taking out, the flexible guard 210 with flared distal end can extend through pipe box and place, thus is taking out this pawl of process of capsule from pipe box elongate distal end (see Figure 37).When being extracted in pipe box 204 by capsule, guard shield 210 helping directive capsule reaches compressive state.Once take out this capsule, pipe box 210 has taken out from body through pipe box 204, and takes out pipe box subsequently.

See Figure 38 A and 38B, full capsule 212 can comprise safety harness 216, and it makes this capsule 212 be positioned at the proximal end region of stomach when the primary mechanism of being located by this capsule (such as suture, clip, binding agent etc.) failure.Band 216 extends from this capsule and is fixed on the site 218 of coat of the stomach.Band 216 can be formed with the material of capsule institute type of service, or uses the fiber reinforced ribbon of described material.In the embodiment shown in Figure 38 A and 38B, the proximal part of capsule 212 is fixed on appropriate location at attachment point 214 place suture.If when these are sewed up and connect meeting failure, capsule application band keeps, and prevents the gastric antrum or the Pyloric Region that move to stomach, and prevents occlusive events thus.

There have been described herein the various embodiments of Satiation devices.These embodiments are not formed restriction to scope of the present invention to illustrate mode to provide.In addition should understand, the various features of described embodiment can combine by different way, thus obtain other embodiments many.And, although describe multiple material, size, shape, implantation position etc. to disclosed embodiment, other disclosed schemes in addition can also be adopted and do not exceed scope of the present invention.

Claims (18)

1. cause the device that weight in patients alleviates, this device comprises:

Have the Satiation devices of proximal openings and distal openings, described proximal openings can be positioned in stomach esophageal junction region, so that described proximal openings and esophagus are in line; Described device is proportional, undertaken slowly to make Endo-esophageal food by transmission activity wherein, when proximal openings is located like this, wherein said Satiation devices is stretched to deployed configuration by folding configuration voluntarily, and wherein said Satiation devices comprises at least one supporting structure element; With

Be connected and the tubular extension structure extended from described proximal openings.

2. the device of claim 1, the diameter of wherein said proximal openings is greater than the diameter of distal openings.

3. the device of claim 2, wherein this Satiation devices has nearly funnel shaped.

4. the device of claim 1, wherein this structural detail is made up of shape-memory material.

5. the device of claim 4, wherein this shape-memory material is nitinol.

6. the device of claim 4, wherein this shape-memory material is shape-memory polymer.

7. the device of claim 1, wherein this structural detail is the form of coil.

8. the device of claim 1, wherein this structural detail is made up of net.

9. the device of claim 1, wherein the proximal part of this Satiation devices comprises sewing area.

10. the device of claim 1, comprises the support of the proximal end region being arranged in stomach further, and this Satiation devices can be connected with the proximal part of this support, makes the distal openings of described Satiation devices be stretched over the inside of this support thus.

The device of 11. claim 1, comprises the neck ring of the distal portions being positioned at this Satiation devices further, and this collar compressible to the first diameter is also stretched to Second bobbin diameter to change the diameter of distal openings.

The device of 12. claim 1, comprises the check valve of the distal openings being positioned at Satiation devices further, and this valve is oriented to when implanting this device, and this valve prevents by stomach to the backflow in this Satiation devices.

The device of 13. claim 1, wherein the distal portions of this Satiation devices is made up of elastomeric material.

The device of 14. claim 1, wherein this Satiation devices is made up of bioabsorbable material.

The device of 15. claim 1, wherein said tubular extension structure is the cylindrical stent structure expanded voluntarily.

The device of 16. claim 15, the wherein said stretched out structure expanded voluntarily is made up of marmem.

The device of 17. claim 15, the wherein said stretched out structure expanded voluntarily comprises multiple circle, and it is applicable to expanding from compulsory condition.

The device of 18. claim 1, wherein said Satiation devices comprises the cylindrical chute of the distal openings of contiguous described Satiation devices.